Adventrx Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for its product candidate ANX-530 (vinorelbine injectable emulsion), or Exelbine. The filing of the Exelbine NDA means the FDA has made a threshold determination that it is sufficiently complete to permit a substantive review.
“We are pleased to have reached this important milestone, and look forward to working with the FDA on moving Exelbine toward approval in 2011,” said Brian M. Culley, chief executive officer of Adventrx.
Adventrx is seeking approval of Exelbine for the same indications as Navelbine, a branded formulation of vinorelbine, including non-small cell lung cancer. Adventrx submitted the NDA as a 505(b)(2) application that relies in part on the FDA's findings of safety and effectiveness of a reference drug. The Exelbine NDA includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of Exelbine and Navelbine, the reference drug. In this clinical bioequivalence study, Exelbine and the reference drug were determined by Adventrx to be bioequivalent.
Adventrx retains exclusive worldwide rights to Exelbine, other than in South Korea, China, Hong Kong, Macau and Taiwan. In March 2010, the FDA conditionally accepted “Exelbine” as the proposed proprietary name for ANX-530. The United States Patent and Trademark Office has allowed patent claims related to Exelbine, which claims will issue in January 2011 and expire in November 2027.
Adventrx Pharmaceuticals is a specialty pharmaceutical company whose product candidates are being developed to improve the performance of existing anti-cancer drugs by addressing limitations associated principally with their safety and use.